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www.fdanews.com/articles/108572-ardea-moves-drug-into-phase-ii-study-for-gout

Ardea Moves Drug Into Phase II Study for Gout

July 15, 2008

Ardea Biosciences has received regulatory approval to begin a Phase IIa proof-of-concept clinical trial evaluating RDEA806 in gout patients with hyperuricemia.

Gout is a painful, debilitating disease caused by abnormally elevated levels of uric acid in the blood stream and is the most common form of inflammatory arthritis in men older than 40, according to the company.

The randomized, double-blind, dose-ranging, efficacy and safety trial will be conducted at medical centers in Europe and Canada. To establish normal serum uric acid (sUA) concentrations in gout patients with hyperuricemia, the trial will compare the sUA level of two dose regimens of the drug with placebo.